FDA applicant

Mitaka USA, Inc.

Park City, UT2 decisions1999–19991 recall

FDA records 2 decisions for Mitaka USA, Inc. (Park City, UT) in 1999: 2 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GWG (Endoscope, Neurological). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Mitaka USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mitaka USA, Inc. since 2007.

Recalls per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Mitaka USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Mitaka”

FDA records each applicant name separately; these may or may not be the same firm.

Mitaka Kohki Co., Ltd. 1

Mitaka USA, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Mitaka”